Events

Recall of Device Recall OERPro Endoscope Reprocessor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Olympus Corporation of the Americas.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74542
  • Event Risk Class
    Class 2
  • Event Number
    Z-0138-2017
  • Event Initiated Date
    2016-06-23
  • Event Date Posted
    2016-10-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147873
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accessories, cleaning, for endoscope - Product Code FEB
  • Reason
    New warning requiring users to conduct duodenoscope precleaning and manual cleaning even when using an automated endoscope reprocessor (aer) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.
  • Action
    Olympus America Inc. (OAI) mailed a letter to customers informing them that they are issuing an updated Operation Manual for the OER-Pro Automated Endoscope Reprocessor. The following actions were asked to be taken: -Olympus has discontinued previously distributed copies of the OER-Pro Operation Manual. - Inspect your inventory of Operation Manuals and discard any existing inventory of OER-Pro Operation Manuals. - Implement use of the enclosed OER-Pro Operation Manual, which contains the new Warning on pages 73 and 80. - Ensure all reprocessing personnel are completely knowledgeable and thoroughly trained on the requirement to perform precleaning and manual cleaning of Olympus duodenoscopes prior to placing the duodenoscopes in the OER-Pro for high level disinfection. - Additional copies of the new OER-Pro Operation Manual can be obtained by contacting our Technical Assistance Center at 1-800-848-9024, option 1, or by indicating on the enclosed questionnaire. Additional Operation Manuals will be mailed to your facility - Please indicate on the enclosed questionnaire that you have received this notification. Fax the completed form to (484) 896-7128.

Device

Device Recall OERPro Endoscope Reprocessor
  • Model / Serial
    Model: OER-Pro, All serial numbers affected
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY
  • Product Description
    OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
  • Manufacturer
    Olympus Corporation of the Americas

Manufacturer

Olympus Corporation of the Americas
  • Manufacturer Address
    Olympus Corporation of the Americas, 3500 Corporate Pkwy, PO Box 610, Center Valley PA 18034-0610
  • Manufacturer Parent Company (2017)
    Olympus Corporation
  • Source
    USFDA